AVI Didactic Experience for Latinx Patient Treatment Adherence and Non-English Speaker Trial Enrollment Study in Rad Onc (ADELANTE)

Columbia University

Status: Enrolling

Conditions: Breast Cancer Invasive; Prostate Cancer

Treatments: Other: Audiovisual Intervention- Cancer Clinical Trials Education; Other: NCI Taking Part in Cancer Research Studies Brochure; Other: ASTRO Radiation Therapy for Breast or Prostate Cancer Brochure; Other: Audiovisual Intervention- Radiation Therapy Education

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05351424

AAAT2490

Details and patient eligibility

About

The study aims to develop educational media interventions to prepare Latinx Spanish-speaking radiation oncology patients for a course of breast or prostate cancer radiation therapy and to foster receptivity and informed decision-making around cancer clinical trial participation.

Full description

Research suggests that utilization of audiovisual educational interventions may help to address health literacy and language barriers as well as suboptimal outcomes and trial enrollment in minority and/or non-English speaking patients. However, this has yet to be demonstrated in the radiation oncology setting, in which educational material is limited to written brochures for non-English speaking patients. Herein, the investigators propose to develop and implement a targeted linguistically and culturally appropriate audiovisual intervention (AVI) for Latinx/Spanish-speaking (SS) patients undergoing curative radiotherapy (RT). Our overall objective is to demonstrate benefit of AVI on RT knowledge, adherence, satisfaction and cancer trial perceptivity and enrollment in Latinx/SS patients. The investigators also aim to identify patient-specific and modifiable system-level factors predictive of quality RT delivery and clinical trial accrual to instruct future demographic-segmentation strategies focused on reducing outcomes disparities within radiation oncology.

Enrollment: 194 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Pilot Phase Inclusion Criteria:

1. Spanish speakers of Latinx background as defined by the U.S. Census Bureau as anyone from Mexican, Puerto Rican, Cuban, Dominican, Central or South American ancestry
2. Currently undergoing treatment for breast or prostate cancer, or recently been treated

Pilot Phase Exclusion Criteria:

1. Patient with bilateral deafness and/or blindness
2. Patient with psychosis and/or dementia

Main Study Inclusion Criteria:

1. Spanish speakers of Latinx background as defined by the U.S. Census Bureau as anyone from Mexican, Puerto Rican, Cuban, Dominican, Central or South American ancestry
2. Patients with non-metastatic prostate or breast cancer
3. Histopathologically proven diagnosis of prostate or breast cancer
4. History and physical examination within 28 days prior to enrollment
5. Karnofsky performance status 70 or greater
6. For women of childbearing potential, pregnancy testing to be performed in accordance to institutional guidelines
7. Plan to receive definitive, curative radiation. Patients planning to receive curative RT after upcoming adjuvant chemotherapy or induction hormonal therapy may enroll at reconsult "follow-up" visit.
8. Consultation visit must be performed with a certified interpreter

Main Study Exclusion Criteria:

1. Patient with bilateral deafness and/or blindness
2. Patient with psychosis and/or dementia
3. Clinical or radiological evidence of metastatic disease
4. Prior participation in cancer patient education trial
5. Prior RT
6. RT for sites other than breast or prostate

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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194 participants in 4 patient groups

Audiovisual Intervention- Radiation Therapy Education

Experimental group

Description:

Audiovisual video will be provided to the subjects as educational material.

Treatment:

Other: Audiovisual Intervention- Radiation Therapy Education

Written Brochure- Radiation Therapy Education

Active Comparator group

Description:

Written brochures will be provided to the subjects as educational material.

Treatment:

Other: ASTRO Radiation Therapy for Breast or Prostate Cancer Brochure

Audiovisual Intervention- Cancer Clinical Trials

Experimental group

Description:

Audiovisual video will be provided to the subjects as educational material.

Treatment:

Other: Audiovisual Intervention- Cancer Clinical Trials Education

Written Brochure- Cancer Clinical Trials

Active Comparator group

Description:

Written brochures will be provided to the subjects as educational material.

Treatment:

Other: NCI Taking Part in Cancer Research Studies Brochure